Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis

NCT06069336 | Completed DMC

• 1 other identifier: 1/2023
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 3

Brief Summary

Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.

Conditions

Bronchiolitis

Keywords

hypertonic saline; infants; RCT

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay (LOS).

  From admission to hospital discharge

Secondary Outcomes (7)

• Number of participants requiring oxygen supplementation

  During the intervention

• Duration of oxygen supplementation

  During the intervention

• The time until the infant will be assessed as being 'fit for discharge'

  During the intervention

• Number of participants requiring hospital readmission after discharge

  7 days after the end of interventions

• Number of adverse events

  7 days after the end of interventions

Study Arms (2)

Hypertonic saline

ACTIVE COMPARATOR

3% hypertonic saline (NEBU-dose hypertonic). The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge.

Drug: Hypertonic saline

Normal saline

PLACEBO COMPARATOR

0,9% normal saline (NEBU-dose isotonic).The treatment will be delivered through nebulisation using oxygen with 5 litres of O2 flow, or through a compressed air-driven jet nebuliser, every 6 hours for three times daily with a night break, until discharge.

Drug: Normal saline

Interventions

Hypertonic saline DRUG

Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse

Hypertonic saline

Normal saline DRUG

0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse

Normal saline

Eligibility Criteria

• Age: 5 Weeks - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children admitted to the hospital with the clinical diagnosis of acute bronchiolitis, which is defined as an apparent viral respiratory tract infection associated with airway obstruction manifested by at least one of following symptoms:
• Tachypnoea (WHO definition).
• Increased respiratory effort manifested as follows:
• Nasal flaring;
• Grunting;
• Use of accessory muscles;
• Intercostal and/or subcostal chest wall retractions;
• Apnoe.
• Crackles and/or wheezing.
• Aged 5 weeks - 24 months old.
• A caregiver must provide written informed consent.

You may not qualify if:

• Infants hospitalised with severe bronchiolitis (requiring mechanical ventilation or intensive care, or oxygen saturation \< 85% on room air).
• History of prematurity (gestational age \<34 weeks).
• Diagnosis of a clinically significant chronic disease (cardiac, respiratory, neuromuscular, or metabolic).
• Immunodeficiency.
• Gastro-oesophageal reflux.
• Diagnosis or suspicion of asthma.
• Inhaling a nebulised 3% hypertonic saline solution within 12 hours before enrolment.
• Inhaling bronchodilators within 24 hours before enrolment.
• Inhaling steroids within 24 hours before enrolment.
• Systemic steroid therapy in the preceding 2 weeks.

Sponsors & Collaborators

• Szpital im. Św. Jadwigi Śląskiej: lead

Study Sites (3)

Szpiatal im.Świętej Jadwigi Śląskiej

Trzebnica, 55-100, Poland

Location

Dziecięcy Szpital Kliniczny im. Polikarpa Brudzińskiego w Warszawie

Warsaw, 02-091, Poland

Location

Specjalistyczny Szpital im. Alfreda Sokołowskiego w Wałbrzychu

Wałbrzych, 58-309, Poland

Location

Related Publications (1)

• Szupienko S, Buczek A, Szymanski H. Nebulised 3% hypertonic saline versus 0.9% saline for treating patients hospitalised with acute bronchiolitis: protocol for a randomised, double-blind, multicentre trial. BMJ Open. 2023 Nov 27;13(11):e080182. doi: 10.1136/bmjopen-2023-080182.

  PMID: 38011984 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic; Saline Solution

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Paediatric Department

Model Details: Randomization will occur within 24 hours of admission

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: October 5, 2023
• Study Start: November 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Avaliable after the publication
• Access Criteria: Upon researcher's personal request

Locations

PL (3)